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Total Preoperative MR Diagnostic Evaluation Versus Standard Diagnostic Evaluation in Patients With Rectal Cancer

NCT01544452 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2014-12-02

No results posted yet for this study

Summary

Patients with rectal cancer undergo MRI of the rectum, CT of the thorax and abdomen (or thorax x-ray and ultrasonic liver evaluation) and colonoscopy as a total diagnostic evaluation before surgery. MR colonography have been shown to have high sensitivity and specificity for larger polyps and cancer and MRI of the liver have been shown to have similar or higher sensitivity than CT of the liver for metastasis. Since patients already undergo MR of the rectum, the investigators have proposed a total diagnostic evaluation with MRI of the liver, abdomen, colonography and rectum in one session (minus thorax evaluation) instead of two or three different methods of evaluation. The investigators hypothesis is that the total MR evaluation is equal or superior to the existing preoperative evaluation regarding the diagnosis of synchronous cancers and liver metastasis and regarding cost-benefit for the total diagnostic evaluation.

Conditions

Interventions

PROCEDURE

MR colonography and MR of the liver

Altered planned surgical procedure if MR colonoscopy reveals synchronous cancer or larger polyps

PROCEDURE

Standard diagnostic evaluation

Altered planned surgical procedure if MR colonoscopy reveals synchronous cancer or larger polyps

Sponsors & Collaborators

  • Herlev Hospital

    lead OTHER

Principal Investigators

  • Michael P Achiam, MD, Ph.D. · Herlev Hospital

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • Denmark

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01544452 on ClinicalTrials.gov